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FDA 510(k)

MAGNATEK80

K-Number: K983114 · 1998-09-22

ApplicantMagna Advanced Technologies, Inc.
Decision Date1998-09-22
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MAGNATEK80 is the device name listed in this FDA 510(k) record. The listed applicant is Magna Advanced Technologies, Inc.. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K983114. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNATEK80?

MAGNATEK80 is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Magna Advanced Technologies, Inc.. The 510(k) number is K983114.

When did MAGNATEK80 receive FDA 510(k) clearance?

MAGNATEK80 received FDA 510(k) clearance on 1998-09-22, under 510(k) number K983114.

Who is the listed applicant for MAGNATEK80?

The FDA 510(k) record lists Magna Advanced Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGNATEK80?

The FDA product code for MAGNATEK80 is CCK.

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Other records listing Magna Advanced Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K991819MAGNATEK 30K982907MAGNATEK 40K982846MTEK-1400K982405MTEK-1000K981310MAGNATEK C-300K981416MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15

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Related Devices (Code: CCK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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